Randomized trial of Alvarado score and antibiotics therapy as a corporate protocol versus conventional clinical management for acute appendicitis

ISRCTN	ISRCTN23935876
DOI	https://doi.org/10.1186/ISRCTN23935876
Protocol serial number	N/A
Sponsor	Bahman Hospital (Iran)
Funders	Department of Surgery, 22 Bahman Hospital (Iran), Department of Surgery, Iran University of Medical Sciences (Iran)

Submission date: 23/02/2007
Registration date: 02/04/2007
Last edited: 30/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mohammadreza Farahnak
Scientific

Department of Surgery, 22 Bahman Hospital
Imam street
Masjedsoleiman
19674
Iran

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	This study aims to compare incorporating the Alvarado score and outpatient antibiotics with conventional clinical management in the treatment of acute appendicitis.
Ethics approval(s)	22 Bahman Hospital ethics committee, approved on 16 May 2006. Ref: 1014/19
Health condition(s) or problem(s) studied	Acute appendicitis
Intervention	The patients will be randomized according to a computer-generated randomization list into case and control group. The Alvarado score is calculated for both groups by a general practitioner not involved in other stages of the study. The Alvarado scores of the patients in the control group will not be known to the admitting service and surgical team. They will continue with conventional clinical assessment and management. The admitting service and the surgical team are informed of the Alvarado scores of patients in the case group. Afterward, patients of the case group will be divided into 3 management subgroups according to their own Alvarado scores: Subgroup 1 - Alvarado score 4 or less. Discharge, no follow up. Subgroup 2 - Alvarado score 5 to 7. Outpatient antibiotics and observation if practicable. They will be prescribed one dose of intravenous gentamicin, 6 mg/kg, and metronidazole, 500 mg for adults or 15 mg/kg as a loading dose for children. Afterward, patients will be discharged on a 10-day course of co-amoxiclav 625 tablets 3 times daily for adults and oral suspension of co-amoxiclav 312.5, 25 mg/kg per day in divided doses every 8 hours for children (Farabi Pharmaceutical Co, Iran). They will be asked to attend 1 day in the clinic. Subgroup 3 - Alvarado score 8 to 10. Immediate operation. They will be immediately arranged to undergo emergency surgery after intravenous injection of antibiotics loading dose as mentioned above.
Intervention type	Other
Primary outcome measure(s)	1. Time to surgery, from randomization to skin preparation in hours 2. Duration of hospitalization, from randomization to discharge from hospital or emergency service (for out-patients) in hours
Key secondary outcome measure(s)	1. Admission rate 2. Operation rate 3. Nontherapeutic surgeries rate (surgery is called therapeutic when it finds the cause of patients pain and it is pertinent to cure the problem) 4. Perforation with late treatment (PLT) rate (treatment that begins at least 10 hours after randomization is considered late)
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	188
Key inclusion criteria	1. Older than 6 years 2. Admitted initially for the current abdominal pain
Key exclusion criteria	1. Generalized peritonitis 2. Suspected of having any abdominal mass or any abdominal involvement of degenerative or systemic diseases 3. Evidence of any mental disturbances, acute confusional state, or dementia 4. Already have any imaging document including plain radiography, ultrasonography, or computed tomographic scan 5. Patients, childrens parent(s), or admitting surgeon repudiate entry into the study
Date of first enrolment	10/07/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

Iran

Study participating centre

Department of Surgery, 22 Bahman Hospital

Masjedsoleiman
19674
Iran

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	publication	01/09/2007		Yes	No